Gabapentin
Product Images NDC 61919-492

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 61919-492). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Image Description (Dosage)

Table showing gabapentin dosage based on renal function measured by creatinine clearance (mL/min). It lists total daily dose ranges (mg/day) and dose regimens (mg) including different dosing frequencies (TID, BID, QD) for creatinine clearance levels ≥60, 30 to 59, 15 to 29, and below 15. It also includes post-hemodialysis supplemental doses (mg) ranging from 125 to 350 with footnotes about dose adjustments for low creatinine clearance and maintenance dosing during hemodialysis.*

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Image Description (Figure1)

A line graph showing weekly mean pain scores over an 8-week period comparing placebo and Gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, divided into a 4-week dose titration and 4-week fixed dose period. The y-axis shows mean pain score from 0 to 10. Gabapentin data points decline from approximately 6.3 to 4, while placebo remains around 6.2 to 5.9, indicating reduced pain scores with Gabapentin throughout the study.*

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Image Description (Figure2)

A line graph showing weekly mean pain scores over 7 weeks for Placebo and Gabapentin dosages (1800 mg/day and 2400 mg/day). The x-axis represents weeks including a 3-week dose titration and a 4-week fixed dose period, while the y-axis shows mean pain scores ranging from 0 to 10. Gabapentin groups show a decrease in pain scores compared to placebo, with statistically significant differences (p<0.01).*

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Image Description (Figure3)

A bar chart comparing the percentage of responders with at least 50% reduction in pain score at endpoint between placebo (PBO) and gabapentin (GBP) at different doses in two controlled PHN studies. Study 1 shows 12% responders for PBO and 29% for GBP 3600 mg. Study 2 shows 14% responders for PBO, 32% for GBP 1800 mg, and 34% for GBP 2400 mg. Statistical significance is indicated for differences with p-values less than 0.01 and 0.001.*

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Image Description (Figure4)

A scatter plot chart showing the responder rate difference (%) for patients receiving Gabapentin by daily dose (mg) across three studies labeled a, b, and c. The x-axis represents daily dose ranging approximately from 600 to 1800 mg, and the y-axis shows difference percentage from 2 to 22%. The chart illustrates dose-response data for adjunctive therapy in patients 12 years and older with partial seizures.*

FDA Label Image

Image Description (Gaba300label)

Label for GABAPENTIN 300 mg capsules, 60 count, from Direct Rx. The label indicates it is a generic for Neurontin, with each capsule containing 300 mg of gabapentin USP. It includes lot details, discard date of 02/17, packaging and distribution info from Alpharetta, GA, and a barcode with NDC 61919-102-60.*

FDA Label Image

Image Description (Gaba400label)

Label for Gabapentin 400 mg capsules, packaged as 30 capsules per container. The label indicates the product is a generic version of Neurontin, distributed by Direct Rx in Alpharetta, GA. It includes the NDC 61919-492-30, manufacturing information from Caraco Pharm. Labs, and a storage note to keep between 68-77 degrees. The label also states RX only and to keep out of reach of children.*

FDA Label Image

Image Description (Gabapentin100label)

Label for Gabapentin 100 mg capsules, 30 count, distributed by Direct Rx. It states the product is a generic for Neurontin, with NDC 61919-101-30. The label includes lot number, expiration date, manufacturer details (Caraco Pharm. Labs., Ltd., Detroit, MI), and a caution to keep out of reach of children.*

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Image Description (Moleculestructure)

Chemical structure of gabapentin showing a cyclohexane ring bonded to aminomethyl and acetic acid groups.*

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Image Description (Table13)

A data table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies with columns for Study number, Study Duration, Gabapentin Target Dose in mg/day, Patients Receiving Gabapentin, and Patients Receiving Placebo. The table shows study durations of 8 and 7 weeks, gabapentin doses of 1800, 2400, and 3600 mg/day, and patient counts receiving gabapentin or placebo.*

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Image Description (Table2 1)

A table showing treatment-emergent adverse event incidence in controlled add-on trials in patients over 12 years of age for gabapentin versus placebo. It lists adverse events by body system with percentages of patients affected in gabapentin (N=543) and placebo (N=378) groups, including fatigue, somnolence, dizziness, and others occurring at or above 1% frequency in the gabapentin group.*

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Image Description (Table2 2)

A data table presenting adverse reactions associated with Gabapentin therapy under various categories including skin and appendages, urogenital system, special senses, and laboratory deviations. It includes specific conditions such as abrasion, pruritus, impotence, diplopia, amblyopia, and decreased white blood cell count, along with corresponding numerical data values.*

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Image Description (Table3)

A data table presenting treatment-emergent adverse event incidence in controlled trials of Gabapentin versus placebo in postherpetic neuralgia patients. It lists body systems and preferred terms with the percentage of affected patients in both Gabapentin (N=336) and placebo groups (N=227), showing higher incidence rates for events such as dizziness, somnolence, and peripheral edema in the Gabapentin group.*

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Image Description (Tabpe5)

Table showing treatment-emergent adverse event incidence in pediatric patients aged 3 to 12 years from a controlled add-on trial, comparing gabapentin (N=119) and placebo (N=128). Events listed include viral infection, fever, weight increase, fatigue, nausea/vomiting, somnolence, hostility, emotional lability, dizziness, hyperkinesia, bronchitis, and respiratory infection, with percentages for each group.*

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Image Description (Warningstable)

A data table titled 'TABLE 2 Risk by indication for antiepileptic drugs in the pooled analysis' showing incidence of events per 1000 patients in placebo versus drug groups across indications including Epilepsy, Psychiatric, and Other, along with relative risk and risk difference values.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.